Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048887
• Other study ID #: CRN04894-01
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2020
• Est. completion date: April 11, 2022

Study information

• Verified date: September 2023
• Source: Crinetics Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study

• Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential

• ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion Criteria:

• Use of topical, nasal, inhaled, or oral corticosteroids.

• Use of any investigational drug within the past 60 days.

• Have a medically significant illness within 30 days prior to screening.

• Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.

• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.

• Unstable psychological disorder =1 year prior to Screening.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CRN04894 Oral Solution
CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
• Placebo Oral Solution
Placebo

Locations

Country	Name	City	State
United States	QPS-Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ACTH-stimulated serum cortisol		Part 1 - Day 1; Part 2 - Day 10
Other	Change in serum cortisol		Part 1 - up to Day 8; Part 2 - up to Day 20
Primary	Percentage of subjects with treatment-emergent adverse events		Part 1 - up to Day 8; Part 2 - up to Day 20
Primary	Proportion of participants with a clinically significant safety laboratory observation		Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary	Pharmacokinetics (AUC)	Assessment of the plasma area under the curve of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary	Pharmacokinetics (Cmax)	Assessment of the maximum observed plasma concentration of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary	Pharmacokinetics (Tmax)	Assessment of time to maximal CRN04894 concentration (Tmax)	Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary	Pharmacokinetics (T1/2)	Assessment of elimination half-life of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20